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NCT Number: NCT04432246

Electroencephalography Predictors of Repetitive Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder

This study used electroencephalogram (EEG) to predict the efficacy of repetitive transcranial magnetic stimulation (rTMS) in patients with obsessive-compulsive disorder.

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Key information

Conditions

Obsessive Compulsive Disorder (OCD) Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

About this study

Repetitive Transcranial Magnetic Stimulation (rTMS), as a relatively mature non-invasive neuromodulation technology, has been recommended for the treatment of patients with refractory OCD in multinational guidelines. However, due to the treatment setting and the patient's feature, nearly half of the patients have no significant changes after rTMS treatment.

In order to better predict the outcome of rTMS and improve the treatment efficiency, this project intends to look for markers that have a predictive effect at baseline or early treatment. Electroencephalogram (EEG) is a cheap and fast method that usually occurs before the symptoms change, thus it is possible to determine whether the patient has responded to the intervention.

In this project, the supplementary motor area (SMA) is selected as the stimulation target. The individual head magnetic resonance image positioning and navigation and rTMS compatible real-time EEG acquisition technology are used to monitor the resting state of EEG and rTMS single pulse stimulation and changes in neural networks before and after treatment. This is a preliminary exploration looking for effective predictive indicators of efficacy in EEG and the relationship between EEG and symptoms changes. In order to lay the foundation for further research and guide clinical treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age>18 years old;
  • DSM-5 criteria for OCD;
  • Y-BOCS total score > or = 16 ->or＝9 yrs education

Exclusion criteria

  • any additional current psychiatric comorbidity, except for obsessive-compulsive personality disorder serious suicide risk;
  • the inability to receive rTMS because of metallic implants, or history of seizures，or history of head injury, or history of neurosurgery;
  • any major medical disease;
  • pregnancy or nursing of an infant;
  • participation in current clinical study;
  • current use of any investigational drug;
  • TMS/DBS treatment at any point in their lifetime;
  • history of long-time use of benzodiazepines

Treatment and study plan

Continuous theta burst stimulation (cTBS)

Device

50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses

Primary outcomes

  1. Change in symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Time frame: Up to 6 months

    It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.The responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post-treatment.

  2. EEG biomarkers as predictors of response to rTMS

    Time frame: baseline

    TMS-EEG and resting state EEG will be performed to investigate predictors of response to rTMS in OCD patients. The α, β and δ band power in resting state in each brain area of OCD patients will be recorded and analyzed. Also, in TMS treatment, event related potentials (ERPs) including motor evoked potentials (MEPs) amplitude, I waves, α band power and β band power will be analyzed.

Secondary outcomes

  1. Change in The Beck Depression Inventory (BDI)

    Time frame: Up to 6 months

    It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms.

  2. Change in The Beck Anxiety Inventory (BAI)

    Time frame: Up to 6 months

    It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.

  3. Change in The Perceived Stress Scale(PSS)

    Time frame: Up to 6 months

    The Perceived Stress Scale (PSS) has 10 items to assess stress status within four weeks. Items are classified into five levels, from 0 (never) to 4 (very often). Total scores range from 0 to 40. The higher the total score, the stronger the level of stress the patient feels.

  4. Change in Pittsburgh sleep quality index(PSQI)

    Time frame: Up to 6 months

    The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).

  5. Change in Obsessive Compulsive Inventory-Revised(OCI-R)

    Time frame: Up to 6 months

    It is an inventory of OCD symptoms with 18 items that are rated on a 5-point Likert scale. Total scores range from 0 to 72, with higher scores indicating more severe OCD symptoms.

  6. Change in Side-effect questionnaire

    Time frame: Up to 6 months

    It consists of 10-item and uses 0 to 3 severity scale to rate the intensity of side effects. Total scores range from 0 to 30, with higher scores indicating more severe side-effect. It also assesses the relation between side-effect and the effects of rTMS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

Electroencephalography (EEG) Predictors of Repetitive Transcranial Magnetic Stimulation (rTMS) in Obsessive-Compulsive Disorder (OCD): A Preliminary Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2020
Registry last updated
Sep 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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